Evaluation Of Uterine Patency following Sonography-guided Transcervical Ablation of Fibroids

Uterine fibroids or myomata are the most common benign tumors in women. The
prevalence of fibroids is approximately 20-25% in adult women, and the
incidence increases with premenopausal age. The lifetime risk of developing
fibroids is as high as 70% in white women and greater than 80% in black women.
Most fibroids are asymptomatic. However, depending on the size and location of
the tumors, fibroids can be symptomatic and may involve one or more of the
following: heavy menstrual bleeding (HMB), dyspareunia, dysmenorrhea, anemia,
pelvic/abdominal pressure, urinary retention, constipation, subfertility,
pregnancy loss and preterm labor. Because they are prevalent and often
symptomatic, fibroids impact the quality of life of millions of women and are
associated with an increased utilization of health care resources involving
treatments that are often invasive and expensive.
There are several treatment options for uterine fibroids such as the Sonata
System, which combines intrauterine ultrasound (IUUS) with radiofrequency (RF)
ablation. Surgical options for treatment of myomata include hysterectomy and
myomectomy, each of which can be performed via a number of approaches, such as
laparotomy, laparoscopy, and hysteroscopy.
One risk associated with some treatment options is adhesiogenesis. Obliteration
of the endometrial cavity by adhesions can result in amenorrhea (Asherman
syndrome), but lesser degrees of synechiae can impair fecundity and be
associated with abnormal uterine bleeding and secondary dysmenorrhea. The
pathophysiology involves mechanical disruption of the basalis layer of the
endometrium (as after vigorous curettage), preventing endometrial regeneration;
local infection may also predispose to intrauterine adhesiogenesis. With
hysteroscopic myomectomy, there is an overall 1.5% risk of adhesiogenesis 1-3
months after treatment for solitary myomata, but as high as 78% after resection
of two or more apposing myomata. However, hysteroscopic myomectomy involves
resection of extensive areas of endometrium, often including the basalis layer,
whereas focal myoma ablation may or may not involve the endometrium. While some
studies have looked at patients up to three months status-post hysteroscopic
myomectomy, adhesions were noted as early as 1-2 weeks postoperatively and the
majority of studies suggest early second-look hysteroscopy (within 1-4 weeks)
for early detection and lysis of intrauterine adhesions. It should be noted
that Sonata is designed to ablate target fibroid tissue and is not endometrial
ablation. Unlike endometrial ablation, in which there is intentional
obliteration/removal of the entire endometrium that can incite significant
adhesions, the Sonata System delivers RF energy focally to ablate fibroids
beneath the endometrium and does not destroy significant areas of endometrium.
(Please see also Section 4 *Introduction* of the protocol)

The objective of the OPEN Study is to document the presence or absence of
intrauterine adhesions after treatment with the Sonata System when used in
women with submucous and/or transmural fibroids in accordance with product
labeling.

An evaluation for adhesions will be done through second look hysteroscopy.

Post-market prospective, multicenter, single-arm cohort study

Only those subjects for whom the sonata treatment was selected for the
treatment of their fibroids are being asked to participate in the trial. Thus
no additional risk is associated with the Sonata treatment in this trial.
Risks associated with the second-look hysteroscopy are the same as those for
the baseline hysteroscopy, and there are no incremental risks associated with
subsequent hysteroscopies.

Furthermore subjects will receive more medical consultations and observations
than would typically occur outside this study. Early diagnosis of intrauterine
adhesions at 6 weeks after treatment may permit early treatment of these
adhesions.

The anticipated risk/benefit ratio of this study is favorable due to the low
risks inherent with standard diagnostic hysteroscopy relative to the benefit of
increased knowledge regarding the impact of transcervical RF ablation of
uterine fibroids on the potential development of uterine synechiae. The rare
risk of uterine perforation during second-look hysteroscopy at the 6-Week
Follow-up Visit is outweighed by the potential benefits of early detection of
intrauterine adhesions, such as the possibility of early treatment of
adhesion-related issues and preservation of access to the endometrial cavity in
the future.